Clinical trials: Renal Denervation
Hypertension, Vascular Diseases
Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- HTN-4 (NCT01972139)
- Testing
- Renal Denervation using the Symplicity Renal Denervation System, Renal Angiography
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- Medtronic Vascular
Hypertension
To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension
This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in treating patients with uncontrolled essential…
- Trial name
- NCT03261375
- Testing
- Renal Artery Radiofrequency Ablation System (Generator and Catheter ), Antihypertensive Agents
- Where
- 25 sites in China
- Volunteers
- 205 people
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
Hypertension
Renal Denervation Using Externally Focused Therapeutic Ultrasound
This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.
- Trial name
- NCT01926951
- Testing
- Surround Sound Externally Focused Therapeutic Ultrasound
- Where
- 3 sites in Czechia, New Zealand
- Volunteers
- 27 people
- Sponsor
- Kona Medical Inc.
Chronic Heart Failure
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
- Trial name
- NCT04719637
- Testing
- PRDS-001 Renal Denervation Ultrasound System
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
Uncontrolled Hypertension
Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System
This single-arm, non-randomized, open-label investigation aims to collect safety and efficacy data of the CE-Marked Netrod™ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive…
- Trial name
- NCT07061054
- Testing
- Netrod™ six-electrode radiofrequency renal denervation system
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
Hypertension
FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
To verify the safety and effectiveness of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the renal denervation of essential hypertension.
- Trial name
- NCT05590871
- Testing
- FlashPoint renal denervation system
- Where
- 27 sites in China
- Volunteers
- 180 people
- Sponsor
- Shanghai Hongdian Medical CO., LTD
Hypertension, Vascular Diseases
SPYRAL DYSTAL Renal Denervation Global Clinical Study
The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- NCT04311086
- Testing
- Renal Denervation (Symplicity Spyral™)
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Vascular
Uncontrolled Hypertension
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled…
- Trial name
- NCT01699529
- Testing
- Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 50 people
- Sponsor
- Medtronic Vascular
Atrial Fibrillation, Hypertension
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a…
- Trial name
- Symplicity AF (NCT02064764)
- Testing
- Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Arctic Front Advance™ Cardiac Cryoablation System
- Where
- 10 sites in United States, Germany
- Volunteers
- 102 people
- Sponsor
- Medtronic Vascular
Hypertension, Vascular Diseases
Spyral InSight Study
The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- Spyral InSight (NCT07013929)
- Testing
- Renal nerve stimulation
- Where
- 2 sites in Greece, Ireland
- Volunteers
- 19 people
- Sponsor
- Medtronic Vascular
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved…
- Conditions
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
- Trial name
- RDN+AF (NCT01907828)
- Testing
- Renal Artery Ablation, Cardiac Ablation
- Where
- 2 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Abbott Medical Devices
Resistant Hypertension
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with…
- Trial name
- NCT06526858
- Testing
- HyperQureTM Renal Denervation (RDN) System:
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- DeepQure Inc.
Hypertension, Blood Pressure
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.
- Trial name
- EnligHTN-II (NCT01705080)
- Testing
- EnligHTN
- Where
- 33 sites in Australia, France and 9 more
- Volunteers
- 276 people
- Sponsor
- Abbott Medical Devices
Hypertension, Vascular Diseases
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- NCT05198674
- Testing
- Renal Denervation (Symplicity Spyral™)
- Where
- 97 sites in United States, Australia and 9 more
- Volunteers
- 1,899 people
- Sponsor
- Medtronic Vascular
Hypertension
The Peregrine Study: A Safety and Performance Study of Renal Denervation
The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device which is intended to be used to ablate the afferent and efferent sympathetic nerves serving the kidneys.
- Trial name
- NCT02155790
- Testing
- The Peregrine System Infusion Catheter
- Where
- 3 sites in Czechia, Poland
- Volunteers
- 10 people
- Sponsor
- Ablative Solutions, Inc.
Hypertension
Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound
This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy.
- Trial name
- NCT01704170
- Testing
- Kona Externally Focused Ultrasound Therapy
- Where
- 4 sites in Australia, Canada and 1 more
- Volunteers
- 31 people
- Sponsor
- Kona Medical Inc.
Uncontrolled Hypertension
EuroNetrod HTN OFF-Med Study of Renal Denervation With NetrodTM Six-electrode Radiofrequency RDN System
This randomized controlled investigation aims to evaluate the efficacy and safety of the Netrod™ RDN system in patients with uncontrolled primary hypertension in the absence of antihypertensive medication, comparing the outcomes…
- Trial name
- EuroNetrod (NCT06722651)
- Testing
- Netrod™ six-electrode radiofrequency renal denervation system
- Where
- Switzerland
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
Resistant Hypertension
REnAL denervatIon by ultraSound Transcatheter Emission
The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.
- Trial name
- REALISE (NCT01529372)
- Testing
- PARADISE percutaneous renal denervation
- Where
- 2 sites in France
- Volunteers
- 20 people
- Sponsor
- ReCor Medical, Inc.
Hypertension, Vascular Diseases
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc.
- Trial name
- REQUIRE (NCT02918305)
- Testing
- PRDS-001 Renal Denervation Ultrasound System
- Where
- 53 sites in Japan, South Korea
- Volunteers
- 140 people
- Sponsor
- JIMRO Co., Ltd.
Hypertension
Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension
The purpose of this study is to assess the effectiveness of a multi-gene panel to determine which subjects are likely to respond to renal denervation therapy with Medtronic's Symplicity Spyral™ multi-electrode renal denervation…
- Trial name
- GxRDxHTN (NCT04060641)
- Testing
- Geneticure for RDN Genetic Panel
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Geneticure, LLC